Are you an experienced professional looking to take the next step in the clinical research industry?
ICON plc, a global leader in clinical research, is hiring TMF Specialists for its Chennai, India, location! 🏢🌍
📝 About the Role
As a TMF Specialist, you will play a vital role in maintaining the quality, accuracy, and compliance of essential clinical trial documentation. Your key responsibilities include:
- TMF Management:
Managing, maintaining, and auditing the Trial Master File (TMF) as per regulatory requirements (ICH-GCP, SOPs, industry standards). - Document Management:
Ensuring completeness, accuracy, version control, and compliance of all study-related documents—regulatory documents, study files, correspondence, and more. - Cross-functional Collaboration:
Working closely with study managers, CRAs, clinical operations teams, and regulatory affairs personnel to ensure seamless documentation flow.
📚 Requirements
- Experience:
Minimum 1+ years of experience in the eTMF process with solid knowledge of Veeva Vault and clinical documentation workflows. - Education:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field. - Key Skills:
- Deep understanding of clinical trial documentation & regulatory guidelines
- Strong analytical and problem-solving skills
- Ability to work independently and manage multiple deadlines
- Excellent communication and coordination skills
🌟 What You Can Expect
- Competitive Compensation:
Attractive salary package with excellent benefits. - Dynamic Work Culture:
Fast-paced, collaborative, and innovation-driven environment. - Career Growth:
Exposure to global trials, advanced systems, and continuous learning opportunities.
📧 How to Apply
If this role excites you, send your updated resume to:
📝 Tips for TMF Specialists
- Stay Updated:
Keep yourself informed about evolving regulatory expectations and TMF best practices. - Strengthen Analytical Skills:
TMF roles require a keen eye for detail—practice reviewing documents critically. - Collaborate Actively:
Strong communication with study teams ensures better documentation flow and fewer gaps.
🤔 Why Choose ICON plc?
- Industry Leader:
ICON plc is known globally for quality, innovation, and excellence in clinical research. - Skill Development:
Get access to top-tier training, certifications, and career progression. - Supportive Team Culture:
Work alongside experienced professionals committed to delivering impactful clinical research outcomes.